Levita Magnetic Grasper Device Safety and Performance Study

Not Applicable

Completed

• Conditions: Benign Gallbladder Disease
• Interventions: Device: Use of Levita Magnetics Grasper

• Registration Number: NCT02049983
• Lead Sponsor: Levita Magnetics

Brief Summary

The purpose of this study is to determine the Levita Magnetic Grasper Device Safety and Performance in Laparoscopy.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-28
• Study First Submitted QC: 2014-01-29
• Study First Posted: 2014-01-30
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patient is between 18 and 60 years of age

  • Undergoing elective cholecystectomy due to:
  • Cholelithiasis (Gallbladder stones < 2.5cm in longer measurement (length or width))
  • Gallbladder polyps as assessed by ultrasound
  • Absence of non-correctable coagulopathy (INR < 1.4 or, platelet count of < 50,000/mcl)
  • Patient has a body mass index (BMI) ≤ 35 kg/m2 and over 20
  • Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedure

Exclusion Criteria

• Emergency presentation with acute gallbladder disease

  • Pancreatitis
  • Jaundice
  • Scleroatrophic gallbladder as shown by ultrasound
  • Biliary tract stones diagnosed before or during surgery
  • Acute cholecystitis
  • Gallbladder Empyema
  • Ongoing peritoneal dialysis
  • Previous abdominal surgery or laparotomy (presence of any previous upper umbilical incision)
  • Presence of umbilical hernia or previous umbilical hernia
  • American Society of Anesthesiologists (ASA) score of III or IV
  • Patient is undergoing treatment for chronic pain of any origin
  • Significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure)
  • Patients with signs of gallbladder perforation diagnosed by ultrasound
  • Suspicion of biliary cancer
  • Patients with severe peritonitis
  • Contraindications to pneumoperitoneum
  • Known allergy to paracetamol or NSAIDs
  • Patients with metallic implants (such as pacemakers, prosthesis, etc)
  • Previously diagnosed or suspected of having a history of choledocholithiasis based on any alterations in plasma hepatic enzymes
  • Has a biliary tract > 7mm in size as determined by ultrasound
  • Has a gallbladder wall thickness that is > 5mm
  • Diabetic Blood coagulation issues
  • Has signs of hepatic endocrinology (i.e: cirrhosis, liver failure, increase in liver enzymes, etc.)
  • History of endoscopic papillotomy (i.e: Preoperative indication of endoscopic retrograde cholangiopancreatography (ERCP)
  • Patient is pregnant or wishes to become pregnant during the length of study participation or lactation
  • Patient is not likely to comply with the follow-up evaluation schedule
  • Patient is participating in a clinical trial of another investigational drug or device
  • Patient is mentally incompetent or a prisoner
  • Known or suspected drug or alcohol abuse
  • Patient has systemic infection or evidence of any surgical site infection (superficial or organ space)
  • Patient has compromised immune system or autoimmune disease (WBC < 4000 or > 20,000), including prior or pending treatment for HIV or Hep. C
  • Patient intra-operatively needs an additional surgery while undergoing elective cholecystectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Use of Levita Magnetics Grasper	Use of Levita Magnetics Grasper	-

Primary Outcome Measures

Name	Time	Method
Safety Assessment of AEs	During surgery	Absence of any damage or side effect to the patient directly produced by the device during the surgery
Feasibility of Mobilization	Intra-operative	Ability to adequately mobilize the organ during the surgery

Trial Locations

Locations (3)

Hospital Luis Tisne; 🇨🇱 Santiago, Metropolitana, Chile

Hospital Padre Hurtado; 🇨🇱 Santiago, Metropolitana, Chile

Hospital Salvador; 🇨🇱 Santiago, Metropolitana, Chile